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Why is this medication prescribed

Clozapine is used to treat schizophrenia in patients where other medicine has not worked. Clozapine is in a class of medications called antipsychotics. It works by decreasing abnormal excitement in the brain.

Proper Use of This Medicine

Take this medicine exactly as directed. Do not take more of this medicine and do not take it more often than your doctor ordered. Do not miss any doses.

This medicine has been prescribed for your current medical problem only. It must not be given to other people or used for other problems unless you are directed to do so by your doctor.

Dosing

The dose of clozapine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of clozapine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on your special needs.

For oral dosage form (tablets):

For schizophrenia:

Adults At first, 12.5 milligrams (mg) (one half of a 25-mg tablet) once or twice a day. Your doctor may increase your dose as needed. However, the dose usually is not more than 900 mg a day.

Children younger than 16 years of age Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss 2 or more days of clozapine doses, talk to your doctor before you start taking it again. You may need to restart this medicine at a lower dose than you were taking before.

Storage

To store this medicine:

Keep out of the reach of children.

Store away from heat and direct light.

Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.

Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Other uses for this medicine

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

What other information should I know

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For clozapine, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to clozapine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy Clozapine has not been studied in pregnant women. However, clozapine has not been shown to cause birth defects or other problems in animal studies.

Children Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of clozapine in children with use in other age groups.

Older adults Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Clozapine may be more likely to cause side effects in the elderly, including dizziness and fainting, low blood pressure, and confusion or excitement.

Other medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking clozapine, it is especially important that your health care professional know if you are taking any of the following:

Alcohol or

Central nervous system (CNS) depressants (medicines that cause drowsiness) or

Other medical problems The presence of other medical problems may affect the use of clozapine. Make sure you tell your doctor if you have any other medical problems, especially:

Blood diseases or

Enlarged prostate or difficult urination or

Gastrointestinal problems or

Glaucoma, narrow angle or

Heart or blood vessel problems Clozapine may make these conditions worse

Epilepsy or other seizure disorder Clozapine may increase the chance that seizures will occur

Kidney or liver disease Higher blood levels of clozapine may occur, increasing the chance that unwanted effects will occur

Warnings

Clozapine can cause a serious blood condition. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before starting treatment, once a week for the first 6 months, and at least once every other week therafter to check your response to clozapine.Clozapine may cause seizures. Tell your doctor if you have or have ever had seizures. Do not drive a car, operate machinery, swim, or climb while taking clozapine, because if you suddenly lose consciousness you could harm yourself or others.Clozapine may cause swelling of the heart muscle (myocarditis), a condition that can be dangerous. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; difficulty breathing or fast breathing; fever; chest pain; or fast, irregular, or pounding heartbeat.Clozapine may cause low blood pressure and/or dizziness when you stand up, especially when you first start taking it. Tell your doctor if you are taking medications for anxiety such as diazepam (Valium), sleeping pills, or other medications for schizophrenia. Follow your doctor's directions about starting to take a low dose of clozapine and gradually increasing the dose. If you stop taking clozapine for 2 days or longer, talk to your doctor about restarting clozapine on a low dose.

In case of emergency overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.